By NG Biotech | 11.14.16

Test was developed in conjunction with Atomo Diagnostics.

French biotechnology company, NG Biotech, and Australian medical device innovator, Atomo Diagnostics, have developed the world’s first fully integrated blood-based rapid test for detection of hCG levels in pregnancy. The new product, NG-Test Blood Precision hCG, will be unveiled by NG Biotech at Medica 2016 and will be launched commercially early in 2017. Delivering highly accurate results in just 5 minutes, the NG-Test Blood Precision hCG test uses an innovative lateral flow platform developed by multi-award winning medical device design specialists, Atomo Diagnostics, that incorporates a unique integrated buffer delivery mechanism. Testing of hCG (human chorionic gonadotropin) levels is routinely performed in emergency departments when a female patient is admitted with abdominal pain or bleeding. In the region of 20 million hCG tests are performed annually in the US and Europe and, in such cases, either laboratory-based blood analysis is carried out, giving a result in 1 to 2 hours, or a urine rapid test is performed, with results available in 20 to 40 minutes. Urine rapid tests have previously been seen as quick and easy but have proven to be problematic in busy primary care environments. Sample collection can be challenging and time intensive, and urine is a less sensitive sample medium than blood. Insufficient or diluted urine samples can also affect test accuracy and cause false negative results.

In addition, because of the time taken to obtain results, use of blood-based hCG tests in critical point of care (POC) settings has been far from ideal. The new rapid hCG blood test from NG Biotech and Atomo improves greatly on what has gone before, rivaling laboratory-based blood analysis in terms of accuracy. The test has been designed specifically to simplify the test procedure and to reduce the number of user steps by integrating all necessary components into one intuitive, single-use device. The test will mitigate problems commonly associated with standard rapid diagnostic test (RDT) kits; particularly those relating to insufficient blood sample, difficulty with blood collection or transfer to the platform, improper use of buffer or inadequate buffer volume delivery.

Unlike standard, multi-component rapid RDT kits, the device platform designed and developed by Atomo incorporates a built-in safety lancet, unique blood collection and delivery system, and integrated buffer delivery feature, which collectively help to prevent user-related errors and improve test performance. Improved usability means untrained health technicians could potentially perform this new test and diagnostic decisions can be made more promptly, saving time and cost.

Milovan Stankov Puges, CEO of NG Biotech said, “We are proud to have partnered with Atomo Diagnostics to develop our next generation hCG blood test. By combining the talents of our respective companies, we have created a product that addresses unmet user needs in POC testing with superior accuracy, usability, and simplicity. We hope and believe that this will be but the first of many collaborative projects that draw on the assay development expertise of NG Biotech and the device design capabilities of Atomo.”

NG Biotech and Atomo Diagnostics are also partnering to develop new test applications for OTC and POC markets worldwide. John Kelly, CEO of Atomo Diagnostics said, “Atomo has always been committed to improving POC diagnostics by reimaging what has gone before. Our all-in-one AtomoRapid diagnostic test devices are designed to overcome the user issues and reduced levels of sensitivity common with in-field deployment of multi-component test kits. The team at NG shares our passion for innovation and we look forward to extending the scope of our partnership in the future.”

From 2017, NG-Test Blood Precision hCG will be available for use throughout Europe and, thereafter, regulatory approval will be sought for commercialization in the US. Additionally, because of its unmatched usability, NG Biotech intends to seek regulatory approval for an OTC version for lay users. This will give women the ability to test for pregnancy at an early stage, with the greater convenience and precision offered by painless blood-based testing. Requiring only a small blood sample of 10uL collected easily and comfortably from the fingertip, the test will deliver a highly accurate result at any time of day, in contrast to urine tests that have to be used with the first morning urine for utmost accuracy in early stage pregnancy.

The new hCG blood test from NG Biotech will be unveiled at Medica 2016—World Forum for Medicine trade fair, Dusseldorf, Germany, 14 - 17 November. The world’s largest medical trade fair, Medica attracts in the region of 5,000 exhibitors and 130,000 visitors from 120 countries annually.

Atomo is exhibiting in Hall 1, booth F19.

NG Biotech is exhibiting in Hall 3, booth H74.

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